Clinical trial · Interventional
Efficacy and Safety of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis
Efficacy, Safety, and PKPD Study of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis (gMG): an Open-label, Randomized Controlled Trial
NCT06827587CI-TRIAL-00086030not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Title: The Efficacy, Safety, and PK/PD of Efgartigimod Followed by Telitacicept in Generalized Myasthenia Gravis: Protocol of a Randomized Controlled Trial Objective: This study aims to evaluate the efficacy, safety, and pharmacokinetics/pharmacodynamics (PK/PD) of efgartigimod followed by telitacicept in patients with generalized myasthenia gravis (gMG). Specifically, the trial seeks to determine the optimal treatment strategy for gMG by assessing the effect of sequential biologic therapy on disease management. Study Design: This is a multi-center, open-label, randomized controlled trial involving 60 acetylcholine receptor antibody-positive gMG patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Diseases | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Neuromuscular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Efgartigimod + Telitacicept (1-week interval) group | Drug | — | UNRESOLVED |
| Efgartigimod + Telitacicept (2-week interval) group | Drug | — | UNRESOLVED |
| Telitacicept-only group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Efgartigimod + Telitacicept (1-week interval) group
- description
- Starting from Week 0, participants will receive efgartigimod (10 mg/kg) for induction treatment by intravenous infusion over 1 hour, administered once a week for 4 consecutive weeks. After a 1-week interval, at Week 5, participants will receive telitacicept (240 mg) for maintenance treatment, administered once a week by subcutaneous injection for a total of 25 weeks. Follow-up will continue until Week 30.
- interventionNames
- Drug: Efgartigimod + Telitacicept (1-week interval) group
- type
- EXPERIMENTAL
- label
- Efgartigimod + Telitacicept (2-week interval) group
- description
- Starting from Week 0, participants will receive efgartigimod (10 mg/kg) for induction treatment by intravenous infusion over 1 hour, administered once a week for 4 consecutive weeks. After a 2-week interval, at Week 6, participants will receive telitacicept (240 mg) for maintenance treatment, administered once a week by subcutaneous injection for a total of 24 weeks. Follow-up will continue until Week 30.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * The patient voluntarily signs the informed consent form. * Age ≥18 and ≤80 years, regardless of gender. * Meets the diagnostic criteria for Myasthenia Gravis (MG) as per the 2020 China MG Diagnosis and Treatment Guidelines, with serological evidence of positive AChR-Ab. * MG Clinical Classification according to the Myasthenia Gravis Foundation of America (MGFA) Staging System: Grade II-IV. * Patients with fluctuating MG symptoms before enrollment, as indicated by MG-ADL score ≥6 or Quantitative Myasthenia Gravis score (QMG) ≥8, maintained for more than 24 hours. Exclusion Criteria: * Coexisting active autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis, Sjögren's Syndrome, etc. * Patients with active infections, such as Herpes Zoster, HIV, active Tuberculosis, active Hepatitis. * Patients with thymoma who have undergone surgery within the past 6 months. * Patients with malignancies other than thymoma. * Patients with severe liver or renal dysfunction, defined as: Liver function: ALT or AST \> 3 ×ULN (upper limit of normal). Renal function: Glomerular filtration rate (GFR) \< 30 mL/min/1.73m². * IgG ≤ 400 mg/dL. * Patients who have used biologic agents before enrollment and are within 5 half-lives of the drug, such as those who have used Telitacicept within the past 2 months, Efgartigimod within the past 1 month, or Rituximab within the past 6 months. * Patients who have received intravenous immunoglobulin (IVIg) or undergone plasmapheresis within the past 2 months before enrollment. * Patients who have received any live vaccines within 3 months before the study or plan to receive any vaccines during the study. * Pregnant or breastfeeding women, or those planning to conceive during the trial. * Patients with allergies to human-derived biologics. * Patients who have participated in any clinical trial within the 28 days before enrollment or are within 5 half-lives of the investigational drug used in a prior clinical trial. * Other patients deemed unsuitable for enrollment by the investigator (e.g., severe mental disorders).
References
Publications (1)
- DERIVEDLi J, Zhang Y, Deng Y, Li W, Wang Y, Qi F, Zhang Q, Wan B, Li X, Weng Y, Fang Z, Zhang Y, Qu X, Pan S, Yang S, Zhang X. The efficacy, safety, and pharmacokinetics/pharmacodynamics of telitacicept following efgartigimod in generalized myasthenia gravis: protocol of a randomized controlled trial. Front Immunol. 2025 Oct 22;16:1604786. doi: 10.3389/fimmu.2025.1604786. eCollection 2025. PMID 41200184